CHMP positive for Keytruda (pembrolizumab) + chemotherapy to treat first line advanced or recurrent endometrial cancer
Merck Inc.,( known as MSD outside of the United States and Canada) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, for two indications in gynecologic cancers.
The first opinion recommends the approval of Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent, for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy.
The recommendation in primary advanced or recurrent endometrial carcinoma is based on the NRG-GY018 trial, also known as KEYNOTE-868, evaluating Keytruda in combination with carboplatin and paclitaxel, followed by Keytruda as a single agent. In this study, the Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus carboplatin and paclitaxel. If approved, this would mark the third indication for Keytruda in endometrial cancer in Europe.
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